Find Jobs

Find Jobs Near You – Available Work in Your Location

Skip to job details

Back to Results

Apply for this opportunity

To apply for this job, you'll continue to an external website or email application.

Apply Offsite

SumasEdge Corporation

Computer System Validation (CSV) Consultants(Biotech Industry exp is must)(Only Visa Independent Candidate/W2)

Pay: Not specified

Posted: 3 weeks ago

Location: Piscataway, NJ (Onsite)

Last Updated: 2 weeks ago

Hours: Full-Time

Expires: 9/29/2026

Career Insights for Validation Engineer

See where this job fits in the broader career landscape. Knowing your career path helps you see what's possible from here.

Scorecard

Based on New Jersey data

Review key factors to help you decide if this role fits your goals. How is this calculated?

Were these scores useful?

What they do

A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.

$100,105 / year median in New Jersey

-1% projected decline

Explore Career

Job Description

Job Title

Computer System Validation (CSV) Consultants Location
Piscataway, NJ/Chicago, IL (Onsite) Duration
Contract to hire Job Description Responsibilities Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports .

Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . Validate systems including LIMS, SAP, CMMS/calibration platforms , and other GxP-regulated applications. Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews . Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles. Support audits, inspections, CAPAs, deviations, and remediation activities related to computerized systems. Apply GAMP 5 and risk-based validation principles throughout the system lifecycle. Support validation activities involving Caliber

LIMS, SAP

QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable. Required Qualifications 5+ years of Computer System Validation experience within a GxP-regulated environment. Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments•

REQUIRED.

Hands-on experience authoring and executing

IQ/OQ/PQ

protocols . Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation . Experience validating at least two of the following: Laboratory instruments Manufacturing/engineering equipment

LIMS SAP

CMMS/calibration systems Experience working cross-functionally with Quality, IT, Laboratory, Manufacturing, and technical SMEs . Bachelor s degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience. Ability and willingness to work onsite 5 days per week . Candidates must be interested and eligible for a contract-to-hire opportunity